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Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT00327249
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : August 11, 2009
Sponsor:
Information provided by:
AmpliMed Corporation

Brief Summary:
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: imexon Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
Study Start Date : October 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Determine the maximally tolerated dose of imexon in multiple myeloma patients
  2. evaluate the toxicity of imexon
  3. Preliminarily evaluate efficacy in terms of response and progression free survival.

Secondary Outcome Measures :
  1. Evaluate biomarker responses.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced myeloma, with measurable disease as defined in the protocol.
  • Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
  • Able to perform the activities of daily living.
  • Off prior therapy for at least 2-4 weeks depending on the drug.
  • Blood counts and blood chemistries in or near normal range.
  • If female, neither pregnant nor nursing.
  • Willing to use contraceptives to prevent pregnancy.
  • No other serious illnesses.
  • No other active malignancy.
  • No serious infections.
  • No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
  • Prior radiation is permitted.

Exclusion Criteria:

  • Use of corticosteroids for amyloid disorders, or high dose chronic steroids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327249


Locations
United States, Arkansas
Investigational Site 025
Little Rock, Arkansas, United States, 72206
United States, Texas
Investigational Site 008
Houston, Texas, United States, 77030
Sponsors and Collaborators
AmpliMed Corporation

Responsible Party: Evan Hersh, AmpliMed
ClinicalTrials.gov Identifier: NCT00327249     History of Changes
Other Study ID Numbers: AMP-007
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases